Trial Outcomes & Findings for Neural Changes Associated With a Mindfulness-based Intervention for Young Adults With Childhood Maltreatment (NCT NCT02447744)

NCT ID: NCT02447744

Last Updated: 2021-03-23

Results Overview

Changes in the Perceived Stress Scale scores (post- intervention scores minus pre- intervention scores). Relevant time points used in the calculation include baseline scores at enrollment, and post-intervention/waiting period scores after 2 months of intervention or waiting period. Calculations of the change entail post-intervention/waiting period scores minus baseline scores for each individual subject. The Perceived Stress Scale is a 10 item scale (each responded with Likert scale 0-4), the scale score is the sum of all items, thus the full range of PSS scores is 0-40, with higher scores means worse stress. A reduction in PSS scores (i.e., the change scores being negative) indicates subjects have improved after the intervention by becoming less stressed.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 43 participants
• Primary outcome timeframe: After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.
• Results posted on: 2021-03-23

Participant Flow

Participant milestones

Measure	Mindfulness Group This arm receives an 8-week mindfulness based behavioral intervention program. Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.	Waitlist Control Group This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period. Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.
Overall Study STARTED	21	22
Overall Study COMPLETED	15	21
Overall Study NOT COMPLETED	6	1

Reasons for withdrawal

Measure	Mindfulness Group This arm receives an 8-week mindfulness based behavioral intervention program. Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.	Waitlist Control Group This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period. Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.
Overall Study Withdrawal by Subject	3	1
Overall Study Data not collected b/c logistic reasons	3	0

Baseline Characteristics

Neural Changes Associated With a Mindfulness-based Intervention for Young Adults With Childhood Maltreatment

Baseline characteristics by cohort

Measure	Mindfulness Group n=21 Participants This arm receives an 8-week mindfulness based behavioral intervention program. Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.	Waitlist Control Group n=22 Participants This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period. Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.	Total n=43 Participants Total of all reporting groups
Age, Continuous	26.667 years n=5 Participants	25.273 years n=7 Participants	25.953 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	22 participants n=7 Participants	43 participants n=5 Participants

PRIMARY outcome

Timeframe: After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.

Changes in the Perceived Stress Scale scores (post- intervention scores minus pre- intervention scores). Relevant time points used in the calculation include baseline scores at enrollment, and post-intervention/waiting period scores after 2 months of intervention or waiting period. Calculations of the change entail post-intervention/waiting period scores minus baseline scores for each individual subject.

The Perceived Stress Scale is a 10 item scale (each responded with Likert scale 0-4), the scale score is the sum of all items, thus the full range of PSS scores is 0-40, with higher scores means worse stress. A reduction in PSS scores (i.e., the change scores being negative) indicates subjects have improved after the intervention by becoming less stressed.

Outcome measures

Measure	Mindfulness Group n=19 Participants This arm receives an 8-week mindfulness based behavioral intervention program. Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.	Waitlist Control Group n=17 Participants This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period. Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.
Changes in Subjects' Perceived Stress Level	-5.526 score on a scale Standard Error 1.566	1.000 score on a scale Standard Error 1.437

SECONDARY outcome

Timeframe: After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.

Changes in the mindfulness level as measured by the Mindful Attention Awareness Scale (post-intervention scores minus pre-intervention scores).

Relevant time points used in the calculation include baseline scores at enrollment, and post-intervention/waiting period scores after 2 months of intervention or waiting period. Calculations of the change entail post-intervention/waiting period scores minus baseline scores for each individual subject.

The MAAS is a 15-item scale each responded with Likert scale 1-6; the MAAS score calculated as the mean of all items, thus the full range of the score is 1-6, with higher scores meaning more mindful. An increase in MAAS score (i.e., a positive score change )means the subject has improved after the intervention by becoming more mindful.

Outcome measures

Measure	Mindfulness Group n=18 Participants This arm receives an 8-week mindfulness based behavioral intervention program. Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.	Waitlist Control Group n=15 Participants This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period. Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.
Changes of Mindfulness	0.337 score on a scale Standard Error 0.149	0.049 score on a scale Standard Error 0.126

POST_HOC outcome

Timeframe: 2 months

Population: Subjects who completed both baseline and post-intervention/waiting period were entered into analyses. 6 Subjects from the waiting list control group completed a third MRI after completing the mindfulness intervention.

Gray matter density of the right hippocampus is calculated from anatomical MRI data with the SPM software. Percent changes of gray matter density is calculated for each subject. Relevant time points used in the calculation include baseline values at enrollment, and post-intervention/waiting period values after 2 months of intervention or waiting period. Calculations of the change entail post-intervention/waiting period values minus baseline values, then divided by the baseline values to obtain the percent change measure.

Outcome measures

Measure	Mindfulness Group n=21 Participants This arm receives an 8-week mindfulness based behavioral intervention program. Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.	Waitlist Control Group n=21 Participants This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period. Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.
Percent Changes of Right Hippocampal Grey Matter Density	0.8137 Percent change Standard Error 0.3143	-0.9229 Percent change Standard Error 0.2014

Adverse Events

Mindfulness Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waitlist Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sara Lazar

MGH

Phone: 617-724-7108

Email: slazar@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place